About FDA
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Human Subject Protection
Know your rights.
Understand the researcher's responsibilities.
You cannot be involved as a subject in research unless the investigator has obtained your informed consent. An investigator must provide you sufficient opportunity to consider whether or not to participate in clinical research. You have rights and should be aware of the responsibility of the researcher to protect your rights.
General Information
- Institutional Review Boards (IRBs) and Protection of Human Subjects in Clinical Trials
- Frequently Asked Questions about Institutional Review Boards and Clinical Investigators
- From test-tube to patient: New drug development in the United States
FDA Regulations
- Guidance for Institutional Review Boards and Clinical Investigators
- Human Subject Protection (Informed Consent) (21 CFR Part 50)
- Institutional Review Boards (21 CFR Part 56)
- Additional Safeguards for Children involved in Clinical Investigations of FDA-Regulated Products (Interim Rule) (21 CFR Part 50, subpart D)
- Investigational New Drug Application (IND Regulations) (21 CFR Part 312)
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